A catalog of articles written by award winning investigative journalist, Evelyn Pringle.

Saturday, August 7, 2010

DSM Billing Bible - Big Pharma Best Seller

Evelyn Pringle December 27, 2006

One-hundred percent of the experts involved in writing diagnostic criteria for mood disorders and schizophrenia for the, "Diagnostic and Statistical Manual for Mental Disorders (DSM)," have undisclosed financial ties to the pharmaceutical companies whose drugs are used to treat those conditions.

The April 2006 study in the journal, Psychotherapy and Psychosomatics, also determined that more than 80% of the members on the panels involved in decisions related to "anxiety disorders," "eating disorders," "medication-induced movement disorders" and "premenstrual dysphonic disorder" have financial ties to the pharmaceutical industry.

Experts say the importance of the manual, also referred to as the "Psychiatric Billing Bible," cannot be understated, especially for the Big Pharma. The FDA will not approve a drug to treat a disorder that is not included in the DSM and public and private health insurance programs will not pay to treat a disorder that is not listed in the manual.

Medications for the treatment of schizophrenia and mood disorders are the top sellers of all psychiatric drugs in the US. In 2004, antidepressants and antipsychotics became the third and fourth-biggest selling classes of drugs, following cholesterol and heartburn medications, with combined sales of $20.7 billion.

The April study, led by Dr Lisa Cosgrove, a clinical psychologist from the University of Massachusetts, is the first of its kind, and was conducted in part, by sifting through legal files, conflict of interest databases, patent records, journal articles, and other records.

Dr Cosgrove told the Washington Post that she began the research after learning that 5 of six panel members deciding whether certain premenstrual problems should be considered a psychiatric disorder had ties to Eli Lilly, a company that was at the time seeking approval to market Prozac to treat those problems.

"I don't think the public is aware of how egregious the financial ties are in the field of psychiatry," she told the Post.

"The very vocabulary of psychiatry is now defined at all levels by the pharmaceutical industry," according to Dr Irwin Savodnik, assistant clinical professor of psychiatry at the University of California, in a statement to the Chicago Tribune.

A co-author of the study, Sheldon Krimsky, a science policy specialist at Tufts University and author of, "Science in the Private Interest," told the Washington Post, "When someone is establishing a clinical guideline for the bible of psychiatric diagnosis, I would argue they should have no affiliation with the drug companies in those areas where the companies could benefit from those decisions."

Critics say the pill-promoting list of bogus "mental disorders" in the DSM apparently has no end and kids appear to be the most sought after customers. For instance, in the DMS, a child's behavior become an "oppositional defiant disorder," if a child exhibits at least four of eight behavior patterns, four of which are "often argues with adults," "often loses temper," "often touchy or easily annoyed by others" and "often spiteful or vindictive."

And to treat these alleged "disorders" the drug companies have doctors prescribing the strongest, most expensive psych drugs on the market. On November 11, 2006, the New York Times reported that 13-year-old Paul Williams "has had almost as many psychiatric diagnoses as birthdays."

"The first psychiatrist he saw, at age 7," the Times said, "decided after a 20-minute visit that the boy was suffering from depression."

A string of office visits with psychologists, social workers and psychiatrists led to labels with disorders such as "compulsive tendencies," "oppositional defiant disorder," and "pervasive developmental disorder," or some combination of the others.

Each diagnosis was accompanied by a different regimen of drugs. By the time Paul was 11, his mother said, it was bipolar "with it a whole new set of drug prescriptions."

In June 2006, a study in the Archives of General Psychiatry, said the use of antipsychotics to treat children for problems with aggression and mood swings had increased more than 5-fold between 1993 to 2002, even though none of the drugs are approved for children.

The study found that about a third of the kids who received antipsychotics were diagnosed with behavior disorders, such as attention deficit; another third listed psychotic symptoms or developmental problems; and the others were for mood disorders.

In addition to antipsychotics, the study found that more than 40% of the children were also taking one or more other psychiatric drugs.

Experts say the rise in prescribing antipsychotics to children corresponds with the introduction and heavy promotion of the new generation of antipsychotics known as "atypical" antipsychotics which include Risperdal, Zyprexa and Seroquel, promoted as superior to older and much cheaper antipsychotics like Haldol.

Atypicals are FDA approved for very limited uses in the treatment of adults with schizophrenia, psychosis, and bipolar disorder.

Over the past several years, these new antipsychotics have been shown to cause extremely serious side effects. According to Dr Stefan Kruszewski, MD, a Harvard trained psychiatrist from Harrisburg, Pennsylvania, they increase the risk of obesity, diabetes type II, hypertension, cardiovascular complications, heart attacks and stroke.

He says the atypicals were marketed as being safer and easier to tolerate than the older, cheaper antipsychotics because the drug companies said that they would cause fewer neurological injuries like tardive dyskinesia and akathesia.

Those claims have turned out to be totally false Dr Kruszewski says, and "at the same time they continue to cause neurological side-effects like the older antipsychotics."

In addition, the new drugs have been shown to be less effective with children than the old. An August 2006 study by the New York Psychiatric Institute, found that the average response rate in children enrolled in 8 studies taking the new antipsychotics was only 55.7%, compared to 72.3% with children in 13 studies who were taking the older drugs.

The over-prescribing of the atypical drugs to children is found to be most rampant when the cost of the drugs is covered by government health care programs. For instance, a study in the August 3, 2004, Archives of Pediatric Adolescent Medicine, found the number of children in Tennessee covered by the state's Medicaid program, who were prescribed antipsychotics nearly doubled in six years.

The age group with largest increase was children aged 13 to 18 at 116%, followed by a 93% increase in children aged 6 to 12, and perhaps the most alarming was a 61% increase in the use of antipsychotics with preschool children.

In the wake of budget busting costs, the state of Texas hired ACS-Heritage, a medical consulting firm, to investigate the prevalence of psychotropic drugs prescribed to children and billed to the state, and learned that during the months of July and August, 2004, more than 19,400 teens were prescribed antipsychotics, with nearly 98% prescribed for conditions not approved.

In fact, ACS said that almost half of the children did not appear to have a valid diagnosis warranting the use of the drug, and that one-third of the children were on 2 or more drugs.

The drug companies promote the life-long use of antipsychotics. For instance, a Relapse Prevention Booklet (2004), by the Manic-Depression Fellowship, sponsored by Eli Lilly, for Zyprexa states that "bipolar disorder is often a lifelong illness needing lifelong treatment; symptoms come and go, but the illness stays; people feel better because the medication is working; almost everyone who stops taking the medication will get ill again and the more episodes you have, the more difficult they are to treat."

Some states have filed lawsuits against the drug makers to recoup the costs incurred by the over-prescribing of the atypicals for conditions not approved by the FDA, as well as the cost of medical care for citizens injured by the drugs.

A West Virginia lawsuit alleges that Eli Lilly promoted Zyprexa for "off label" conditions including anxiety, sleep disruption, mood swings, attention deficit hyperactivity and dementia. As a result of these actions, the complaint states, Lilly sold more Zyprexa than it would have sold if it had disclosed the risk of diabetes and other diseases.

The lawsuit also alleges that Lilly concealed the dangers of Zyprexa, such as an increased risk of diabetes, resulting in further cost to the state to treat Medicaid recipients who became ill from using the drug.

In June 2005, Lilly paid $690 million to settle claims by an estimated 8,000 people who claimed that before September 2003, the information on Zyprexa labels regarding the risk of hyperglycemia and diabetes was not adequate.

But on an up-note, according to the company's SEC filings, Zyprexa's sales are booming, with $4.2 billion in 2005, or 29% of Lilly's corporate revenue.

All this money for a new drug that has been proven to be no better than the old antipsychotics which cost pennies a day. Referring to a study published in the New England Journal of Medicine, on September 21, 2005, The Age.com, reported that a "US Government-financed study of drugs used to treat schizophrenia has confirmed what many psychiatrists long suspected: newer drugs that are highly promoted and widely prescribed offer few — if any — benefits over older medicines that sell for a fraction of the cost."

As for pushing pills for the mood disorders, with the help of President George Bush's New Freedom Commission on Mental Health, put in place by an executive order as a gift to the drug companies in return for the millions of dollars in contributions, Big Pharma is zeroing in on children, even infants, as customers for Paxil, Zoloft, Prozac, Lexapro, Effexor, and Celexa, by setting up mental health screening programs in schools and daycare centers.

In a 2003 speech, the director of the Substance Abuse and Mental Health Services Administration, Kathryn Power, reported that mental health assessments are increasingly being conducted in "non-mental health settings," and she praised one community for "placing mental health consultants in child care settings."

She also bragged about the federal "Prevention and Early Intervention Grant Program," and noted that the program's goal is to reach children, and babies, before they have a diagnosable problem. At that time, Ms Power said that more than half of the administration's programs were focused on infants and preschoolers.

Mental health screening programs for kids as young as age 0, are being implemented in states all across the country. For instance, in Minnesota an early childhood program is being integrated to ensure all children ages 0 to 5 are screened "early and continuously" and to link children and their families to mental health services.

In Florida, the Florida Strategic Plan for Infant Mental Health Plan is to develop a system to prevent children from 0 to age five from developing emotional and behavioral disorders.

In Illinois, "all children" are to receive social and emotional screens and the schools are to incorporate social and emotional standards as part of the state's learning standards.

Its not as if infant recruitment schemes are necessary considering the record breaking sales of these drugs. According to SEC filings, Pfizer's Zoloft, pulled in $2.5 billion in the first three quarters of 2005, and worldwide, Wyeth's Effexor totaled $3.5 billion in 2005.

But then, Big Pharma would be out of the psych drug business in no time if not for the cooperation of the doctors writing the prescriptions. On August 17, 2005, the Wall Street Journal said, "If the icon of American psychiatry was for years a couch, it is now arguably a pill."

"And that change in focus," the Journal reports, "has brought to prominence a new type of psychiatrist: the psychopharmacologist."

According to the Journal, "these doctors frequently prescribe complex cocktails of drugs for patients with multiple diagnoses of mental illnesses and sometimes prescribe other drugs to counterbalance side effects from the primary drugs."

A 2003 study by the American Psychiatric Association, on "financial disincentives" for psychotherapy found doctors could earn about $263 an hour for holding three 15-minute medication management sessions per hour, compared to about $156 for a single therapy session, which boils down to an hourly pay cut of 41% for doctors doing therapy.

According to Dr Juan Riestra, associate director of medicine in the department of psychiatry at Mountainside Hospital in Montclair, NJ, a psychopharmacologist is often someone "using a trendy word as a marketing device."

When a psychopharmacologist sees 30 or 40 patients a day, as some do, Dr Riestra told the Journal, "it becomes like a factory."